This letter is in response to your electronic submission, received on December 7, 2010 (PNC 1007), requesting on behalf of PTP Group Ltd. (PTP)a non objection letter from FDA confirming the capability of PTP's secondary recycling process to produce post-consumer recycled polyethylene terephthalate (PCR-PET) pellets that are suitable for use at levels up to 100% recycled content in the manufacture of PET containers for contact with all food types under Conditions of Use A through H, as described in Table 2, which can be accessed from the Internet in the Food Ingredients and Packaging section under the Food topic of www.fda.gov.

The PTP's process is a conventional secondary recycling process, which involves sorting, grinding, aqueous-based washing, drying, and extrusion in the presence of a modifying agent authorized under PTP's FCN 649. As the modifying agent is authorized for use in contact with all food types under Conditions of Use C through G, the requested Conditions of Use A through H are not appropriate.

We have reviewed PTP's recycling process as well as the information obtained from surrogate testing and migration modeling which were submitted to demonstrate the capability of the PTP's secondary recycling process to remove potential contaminants from PCR-PET. Based on our review of these data, we have determined that PTP's secondary recycling process, as described in the subject submission, would be effective in reducing potential contaminants from PCR-PET to levels that result in dietary concentrations not to exceed 0.5 ppb, FDA's threshold of regulatory concern. This determination covers the use of PCR-PET derived from the feedstock that consists of post-consumer food and non-food PET containers (excluding industrial PET containers), provided that the PCR-PET complies with the existing applicable authorizations.

Although we have concluded that the subject PTP's secondary recycling process would produce PCR-PET pellets that are suitable for use at levels up to 100% recycled content in the manufacture of articles for contact with all food types under Conditions of Use A through H, the finished recycled PET pellets would be allowed for use only under Conditions of Use C through H, as limited by the modifying agent used in the process. If the modifying agent is authorized via a new FCN in the future to cover expanded Conditions of Use A through H, the same recycling process does not need to be re-evaluated. If the PTP's recycling process is modified, new surrogate testing data may need to be evaluated.

The resultant PCR-PET material must comply with all applicable authorizations including 21 CFR § 174.5 General provisions applicable to indirect food additives. For example, in accordance with section 402(a)(3) of the Federal Food, Drug and Cosmetic Act, use of the recycled PCR-PET material should not impart odor or taste to food rendering it unfit for human consumption.

If you have any further questions concerning this matter, please do not hesitate to contact us.